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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reamer
Product CodeHTO
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2015 654 654
2016 1039 1039
2017 1234 1234
2018 1835 1835
2019 1955 1955
2020 1531 1531
2021 4802 4802
2022 3909 3909
2023 4405 4405
2024 1618 1618

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 12610 12610
Dull, Blunt 3684 3684
Break 2392 2392
Naturally Worn 2183 2183
Corroded 1697 1697
Material Twisted/Bent 712 712
Device-Device Incompatibility 689 689
Adverse Event Without Identified Device or Use Problem 542 542
Material Deformation 362 362
Appropriate Term/Code Not Available 329 329
Entrapment of Device 310 310
Illegible Information 287 287
Crack 208 208
No Apparent Adverse Event 155 155
Fracture 138 138
Material Discolored 128 128
Material Fragmentation 126 126
Contamination /Decontamination Problem 104 104
Detachment of Device or Device Component 86 86
Mechanical Jam 83 83
Scratched Material 75 75
Device Operates Differently Than Expected 62 62
Device Contamination with Chemical or Other Material 50 50
Pitted 47 47
Component Missing 47 47
Loose or Intermittent Connection 46 46
Degraded 43 43
Material Integrity Problem 33 33
Device Contaminated During Manufacture or Shipping 32 32
Insufficient Information 28 28
Bent 24 24
Difficult to Insert 24 24
Fitting Problem 24 24
Physical Resistance/Sticking 23 23
Unintended Movement 23 23
Connection Problem 21 21
Improper or Incorrect Procedure or Method 15 15
Disassembly 15 15
Material Erosion 15 15
Detachment Of Device Component 13 13
Use of Device Problem 13 13
Difficult to Remove 13 13
Mechanical Problem 12 12
Product Quality Problem 10 10
Peeled/Delaminated 9 9
Device Slipped 8 8
Sticking 7 7
Failure To Adhere Or Bond 7 7
Device Disinfection Or Sterilization Issue 7 7
Difficult to Open or Close 6 6
Component Falling 6 6
Device Reprocessing Problem 6 6
Failure to Advance 6 6
Structural Problem 5 5
Material Separation 5 5
Metal Shedding Debris 5 5
Failure to Clean Adequately 5 5
Separation Failure 4 4
Packaging Problem 4 4
Device Damaged Prior to Use 4 4
Patient-Device Incompatibility 4 4
Positioning Failure 4 4
Off-Label Use 4 4
Complete Blockage 3 3
Loss of or Failure to Bond 3 3
Tear, Rip or Hole in Device Packaging 3 3
Defective Component 3 3
Positioning Problem 3 3
Difficult to Open or Remove Packaging Material 3 3
Device Dislodged or Dislocated 2 2
Compatibility Problem 2 2
Difficult to Advance 2 2
Device Difficult to Maintain 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Distortion 2 2
Noise, Audible 2 2
Material Split, Cut or Torn 2 2
Device Inoperable 2 2
Inadequacy of Device Shape and/or Size 2 2
Problem with Sterilization 2 2
Failure to Align 2 2
Cut In Material 2 2
Device Or Device Fragments Location Unknown 2 2
Defective Device 2 2
Delivered as Unsterile Product 2 2
Unintended Collision 1 1
Unsealed Device Packaging 1 1
Particulates 1 1
Material Puncture/Hole 1 1
Difficult To Position 1 1
Migration or Expulsion of Device 1 1
Misassembled 1 1
Misconnection 1 1
Monitor failure 1 1
Hole In Material 1 1
Difficult or Delayed Positioning 1 1
Flaked 1 1
Disconnection 1 1
Device Tipped Over 1 1
Dent in Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14320 14320
No Consequences Or Impact To Patient 5232 5232
No Information 1153 1153
No Known Impact Or Consequence To Patient 830 830
Insufficient Information 641 641
No Code Available 558 558
Foreign Body In Patient 368 368
No Patient Involvement 270 270
Not Applicable 218 218
Device Embedded In Tissue or Plaque 117 117
Bone Fracture(s) 75 75
Sedation 42 42
Pain 39 39
Injury 34 34
Unspecified Infection 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Blood Loss 19 19
Unspecified Tissue Injury 16 16
Non-union Bone Fracture 12 12
Limb Fracture 10 10
Failure of Implant 10 10
Septic Shock 5 5
Shock 4 4
Tissue Damage 4 4
Loss of Range of Motion 4 4
Hemorrhage/Bleeding 4 4
Hip Fracture 4 4
Post Operative Wound Infection 3 3
Low Blood Pressure/ Hypotension 3 3
Hematoma 3 3
Discomfort 3 3
Nerve Damage 2 2
Debris, Bone Shedding 2 2
Embolism 2 2
Fall 2 2
Impaired Healing 2 2
Patient Problem/Medical Problem 2 2
Inadequate Osseointegration 1 1
Alteration In Body Temperature 1 1
Test Result 1 1
Skin Tears 1 1
Deformity/ Disfigurement 1 1
Joint Disorder 1 1
Hyperextension 1 1
Swelling/ Edema 1 1
Paresthesia 1 1
Unspecified Nervous System Problem 1 1
Foreign Body Reaction 1 1
Wound Dehiscence 1 1
Host-Tissue Reaction 1 1
Ossification 1 1
Pulmonary Embolism 1 1
Anemia 1 1
Arthritis 1 1
Bradycardia 1 1
Burn(s) 1 1
Cyst(s) 1 1
Death 1 1
Neurological Deficit/Dysfunction 1 1
Laceration(s) 1 1
Necrosis 1 1
Respiratory Distress 1 1
Staphylococcus Aureus 1 1
Physical Entrapment 1 1
Perforation of Vessels 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Nov-09-2018
2 Biomet, Inc. II May-26-2016
3 Cayenne Medical Inc. II Jul-25-2018
4 Encore Medical, Lp II Aug-31-2017
5 Synthes (USA) Products LLC II Mar-01-2024
6 Synthes (USA) Products LLC II Dec-15-2020
7 Synthes (USA) Products LLC II Mar-05-2018
8 Synthes (USA) Products LLC II Nov-23-2016
9 Synthes (USA) Products LLC II Nov-19-2016
10 Synthes (USA) Products LLC II Jun-06-2016
11 Synthes (USA) Products LLC II Jan-05-2016
12 Synthes (USA) Products LLC II Aug-10-2015
13 Synthes, Inc. II Jul-16-2015
14 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Mar-20-2020
15 Trilliant Surgical Ltd. II Aug-24-2015
16 Zimmer, Inc. II Feb-06-2023
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